EVO101 Cream for Hidradenitis Suppurativa
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Virginia Clinical Research, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to learn if drug EVO101 works to treat mild to moderate hidradenitis suppurativa in adults. The main questions it aims to answer are:
Does drug EVO101 lower the total number of lesion a participant has from the first visit to the last visit.
What medical problems do participants have when applying drug EVO101 Does a participant perceive a change in their hidradenitis suppurativa symptoms based on patient reported outcome questionnaires.
Participants will:
Apply EVO101 topical cream 0.1% topically Visit the clinic four times unless the first and second appointment have to be done separately then there will be five clinic visits and one phone call over a twelve week period.
Keep a dosing diary
Is the drug EVO101 Cream a promising treatment for Hidradenitis Suppurativa?Based on the provided research articles, there is no direct information about EVO101 Cream or its effectiveness for Hidradenitis Suppurativa. Therefore, we cannot determine if it is a promising treatment from the given data.1241113
What data supports the idea that EVO101 Cream for Hidradenitis Suppurativa is an effective treatment?The available research does not provide specific data on the effectiveness of EVO101 Cream for Hidradenitis Suppurativa. However, it mentions other treatments like adalimumab and infliximab, which have shown effectiveness in improving quality of life for patients with this condition. Adalimumab given weekly and infliximab were found to be effective, while adalimumab every other week was not. Additionally, IL-17 inhibitors like secukinumab and brodalumab have shown positive responses in a significant number of patients. Without specific data on EVO101, it's unclear how it compares to these treatments.5671014
What safety data is available for EVO101 Cream for Hidradenitis Suppurativa?The provided research does not contain specific safety data for EVO101 Cream or its variants (EVO 101, EVO-101) for Hidradenitis Suppurativa. The articles focus on other topics such as chemical safety databases, adverse events from dietary supplements, adalimumab safety in psoriasis, and adverse effects of cosmetics and biologics. Therefore, no relevant safety data for EVO101 Cream is available in the given research.3891215
Do I need to stop my current medications to join the trial?Yes, you may need to stop certain medications. You cannot use topical or systemic antibiotics for HS, certain systemic therapies, or specific topical treatments close to the start of the trial. Some medications require a washout period of up to 12 weeks. Check with the trial team for details on your specific medications.
Eligibility Criteria
Adults with mild to moderate hidradenitis suppurativa, a skin condition that causes small, painful lumps under the skin. Participants must be willing to apply a topical cream, visit the clinic up to five times, and keep a dosing diary over twelve weeks.Inclusion Criteria
I am 18 years old or older.
I agree not to use any antibiotics for HS during the study.
Exclusion Criteria
I am not pregnant or breastfeeding.
Treatment Details
The trial is testing EVO101 topical cream (0.1%) for treating hidradenitis suppurativa. It aims to see if this treatment reduces the number of lesions from first to last visit and improves symptoms based on patient questionnaires.
1Treatment groups
Experimental Treatment
Group I: Open label EVO101 topical cream 0.1%Experimental Treatment1 Intervention
All eligible subjects will receive open label EVO101 topical cream 0.1%
Find a clinic near you
Research locations nearbySelect from list below to view details:
Virginia Clinical Research, Inc.Norfolk, VA
Loading ...
Who is running the clinical trial?
Virginia Clinical Research, Inc.Lead Sponsor
Evommune, Inc.Industry Sponsor
References
Clinical comparison of alclometasone dipropionate cream 0.05% with hydrocortisone butyrate cream 0.1% in the treatment of atopic dermatitis in children. [2017]Alclometasone dipropionate cream 0.05% was compared to hydrocortisone butyrate cream 0.1% in the treatment of atopic dermatitis in forty children, 5 to 11 years old. In this double-blind, parallel-group trial, the experimental creams were applied twice daily for 2 weeks, without occlusion, to the study areas. Efficacy was evaluated 1 and 2 weeks after the start of treatment. Both creams were effective treatments for atopic dermatitis; however, alclometasone dipropionate was judged slightly more efficacious. Improvement in erythema, induration, and pruritus averaged 76% for alclometasone dipropionate-treated patients and 70% for hydrocortisone butyrate-treated patients. At the end of treatment, the physician's global evaluation indicated nineteen of twenty patients in the alclometasone dipropionate group had between 51% and 100% improvement in disease signs and symptoms, compared with sixteen of twenty patients treated with hydrocortisone butyrate. Two patients in the alclometasone dipropionate-treated group and one in the hydrocortisone butyrate-treated group reported mild stinging.
SCH 370 (clotrimazole-betamethasone dipropionate) cream in patients with tinea cruris or tinea corporis. [2014]The safety and efficacy of SCH 370 (1 percent clotrimazole/0.05 percent betamethasone dipropionate) cream was compared with each of its individual components in 331 patients with tinea cruris or tinea corporis. The study was a multicentered, randomized, double-blind, parallel-groups design. The patients received one of three treatments applied twice a day for two weeks and returned for a follow-up visit two weeks after the last application. Total signs and symptoms scores of infections were evaluated at baseline, once between days three to five, and after weeks one, two, and four. Culture and potassium hydroxide preparations were done at baseline and weeks two and four. SCH 370 cream demonstrated more rapid therapeutic activity than the antifungal agent alone, resulting in significantly better clinical results in early treatment and in midtreatment. As expected with a steroid, betamethasone dipropionate achieved relief of inflammatory signs and symptoms early in the course of treatment, but SCH 370 was superior from one week on in the patients with tinea cruris and at post-treatment in the patients with tinea corporis. Mycologically, SCH 370 cream and clotrimazole were comparable at the end of the study and results were significantly better than those for betamethasone dipropionate. All three treatments were safe with no reports of unexpected or serious adverse experiences.
Notification of undesirable effects of cosmetics and toiletries. [2015]An undesirable effect (UE) of a cosmetic product is a harmful reaction attributable to its normal or reasonably foreseeable use. However, the knowledge of UEs, at the population level, is limited by the absence of formal and reliable cosmetovigilance systems, which nevertheless are characterized by underreporting. To test the feasibility of the collection of UEs in our territory we have carried out a pilot project aimed to assess either the notification procedures or the validation/evaluation of the collected forms in our territory. As reporting categories, we have chosen dermatologists and community pharmacists who were asked to notify UEs to cosmetics through a reporting form we have set up. During the period July 2006-December 2007, we have registered 76 reporting forms. Dermatologists who have sent 47 reporting forms represented the main reporting category, followed by community pharmacists (15 reports), other health professionals (9 reports) and consumers (5 reports). Several drawbacks, mainly represented by the incompleteness and inaccuracy of the filled in forms, affected the validation process. Thus, on receipt, we could validate only 34 forms and only after a careful check with each single reporter, we could include in the study other 36 forms. The validation of the collected reports has stressed the importance of a well-structured reporting form, an easy access to notification procedures as well as education and training programme. The evaluation of the validated forms has revealed the need of a controlled term vocabulary for the classification of the observed events and diagnosis, especially with regard to cutaneous reactions that represented almost the totality of the reported events (95.7%). Among the events (n=45) reported by dermatologists, 22 were diagnosed as allergic contact dermatitis (ACD) and 18 as irritant contact dermatitis (ICD). Facial care products (19.7%), followed by body care products (16.9%), perfumes (12.7%) and eye care products (11.3%) were the cosmetics mainly suspected to be responsible for the observed events. Correspondingly, face (n=37), including periorbital and perioral area, forehead, ocular mucous membrane and lips, followed by entire body (n=9) were the body sites reported as more involved. In conclusions, our experience allowed us to identify the main pitfalls of the system we have experienced. These are setting/formulation of the reporting form, notification step, description of the event and diagnosis. A careful settlement of these aspects could substantially contribute to the establishment of an efficient reporting system, although the bias due to underreporting is difficult to eliminate.
Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. [2015]This double-blind controlled phase II study was conducted to compare a newly developed formulation of mometasone furoate with a water content of 33% (Monovo® Cream) and with a smooth consistency versus the commercially available fatty cream of mometasone furoate (Ecural® Fettcreme) in terms of efficacy, cosmetic properties, and patients' acceptance. In 20 patients with mild to moderate atopic eczema, the preparations were tested intraindividually in a randomized mode and in two comparable lesion areas. Both preparations were equally effective and well tolerated. Due to improved cosmetic properties, the new formulation was preferred by the patients when asked for preferential use. Quality of life could be improved by treating with both preparations.
Interventions for hidradenitis suppurativa: a Cochrane systematic review incorporating GRADE assessment of evidence quality. [2018]More than 50 interventions have been used to treat hidradenitis suppurativa (HS), and so therapy decisions can be challenging. Our objective was to summarize and appraise randomized controlled trial (RCT) evidence for HS interventions in adults. Searches were conducted in Medline, Embase, CENTRAL, LILACS, five trials registers and abstracts from eight dermatology conferences until 13 August 2015. Two review authors independently assessed study eligibility, extracted data and assessed methodological quality. Primary outcomes were quality of life and adverse effects of the interventions. Twelve trials, from 1983 to 2015, investigating 15 different interventions met our inclusion criteria. The median trial duration was 16 weeks and the median number of participants was 27. Adalimumab 40 mg weekly improved the Dermatology Life Quality Index (DLQI) by 4·0 points, which equates to the minimal clinically important difference for the scale, compared with placebo (95% confidence interval -6·5 to -1·5 points). Evidence quality was reduced to 'moderate' because the results are based on only a single study. Adalimumab 40 mg every other week was ineffective in a meta-analysis of two studies comprising 124 participants. Infliximab 5 mg kg(-1) improved the DLQI score by 8·4 points after 8 weeks in a moderate-quality study completed by 33 of 38 participants. Etanercept 50 mg twice weekly was ineffective. Inclusion of a gentamicin sponge prior to primary closure did not improve outcomes. Other interventions, including topical and oral antibiotics, were investigated by relatively small studies, preventing treatment recommendations due to imprecision. More, larger RCTs are required to investigate most HS interventions, particularly oral treatments and surgical therapy. Moderate-quality evidence suggests that adalimumab given weekly and infliximab are effective, whereas adalimumab every other week is ineffective.
Interventions for Hidradenitis Suppurativa: Updated Summary of an Original Cochrane Review. [2018]Which treatments have been shown to be effective in randomized clinical trials (RCTs) for hidradenitis suppurativa (HS) in adults?
A core domain set for hidradenitis suppurativa trial outcomes: an international Delphi process. [2022]There is no consensus on core outcome domains for hidradenitis suppurativa (HS). Heterogeneous outcome measure instruments in clinical trials likely leads to outcome-reporting bias and limits the ability to synthesize evidence.
Systematic review of the real-world evidence of adalimumab safety in psoriasis registries. [2019]Long-term safety of adalimumab in psoriasis clinical studies has been established. The objective of this research was to review real-world evidence of adalimumab safety from registries of adult patients with psoriasis treated in clinical practice. Databases (BIOSIS Previews, Current Contents Search, Derwent Drug File, EMBASE, EMBASE Alert, EMCare, MEDLINE, SciSearch) were searched for psoriasis registries with adalimumab safety data. Eligible papers were English language manuscripts (conference abstracts excluded) from psoriasis registries presenting safety data for adult patients with psoriasis receiving adalimumab. The incidence and rate (events/100 patient-years [PY]) of adverse events (AEs), serious AEs (SAEs) and AEs of special interest are reported. Abstracts of 425 publications were screened, and 401 publications excluded (208 conference abstracts; 193 papers). Remaining manuscripts were fully screened; 14 were excluded (no adalimumab data, n = 10; no safety data, n = 2; no on-treatment data, n = 1; not English, n = 1), and 10 selected. Overall rates of AEs (4273 [22.2/100PY]) and SAEs (827 [4.3/100PY]) were reported in the ESPRIT registry (N = 6059). Rates of infections (7.7-14.7/100PY) and serious infections (
Nationwide Online Survey to Complement the Current Voluntary Reporting System for Adverse Events Associated with Dietary Supplements: Application to the Case of Skin Manifestations. [2019]The current adverse event reporting system for dietary supplements lacks the ability to collect and analyze ongoing case reports in sufficient numbers to detect health issues. We conducted an online survey to collect data on skin manifestations due to supplement use in consumers and to identify the suspected products and ingredients. An online survey was conducted among 63,737 dietary supplement users in 2016. Those who self-reported experiences of skin anthema or itching caused by supplement use and recognized a causal relationship as almost certain (0.8%) were invited to provide further details of symptoms and products. Most of the users experienced mild symptoms with "itching and/or rash of body part." After the onset of skin manifestations, 69.3% ceased supplement use, while 26.6% continued supplement use, including those who reduced the amount or frequency of use. Respondents who visited the hospital in response to symptoms accounted for 26.0%, while 53.3% did not seek treatment. The products used were identified in 155 of 300 eligible respondents. Although those products were composed of multiple ingredients, the accumulated data suggested that cutaneous symptoms were related to the following constituents: "Peptides or animal by-products" (31.0%), "Herbal/Botanical" (23.2%) and "Fats and lipid" (13.5%). Conducting an online survey to elicit information directly from consumers identified components of supplements that are involved in skin manifestations that could lead to serious damage, and may fill a void in the current adverse event reporting system.
Hidradenitis suppurativa/acne inversa: a practical framework for treatment optimization - systematic review and recommendations from the HS ALLIANCE working group. [2020]Hidradenitis suppurativa (HS)/acne inversa is a debilitating chronic disease that remains poorly understood and difficult to manage. Clinical practice is variable, and there is a need for international, evidence-based and easily applicable consensus on HS management. We report here the findings of a systematic literature review, which were subsequently used as a basis for the development of international consensus recommendations for the management of patients with HS. A systematic literature review was performed for each of nine clinical questions in HS (defined by an expert steering committee), covering comorbidity assessment, therapy (medical, surgical and combinations) and response to treatment. Included articles underwent data extraction and were graded according to the Oxford Centre for Evidence-based Medicine criteria. Evidence-based recommendations were then drafted, refined and voted upon, using a modified Delphi process. Overall, 5310 articles were screened, 171 articles were analysed, and 65 were used to derive recommendations. These articles included six randomized controlled trials plus cohort studies and case series. The highest level of evidence concerned dosing recommendations for topical clindamycin in mild disease (with systemic tetracyclines for more frequent/widespread lesions) and biologic therapy (especially adalimumab) as second-line agents (following conventional therapy failure). Good-quality evidence was available for the hidradenitis suppurativa clinical response (HiSCR) as a dichotomous outcome measure in inflammatory areas under treatment. Lower-level evidence supported recommendations for topical triclosan and oral zinc in mild-to-moderate HS, systemic clindamycin and rifampicin in moderate HS and intravenous ertapenem in selected patients with more severe disease. Intralesional or systemic steroids may also be considered. Local surgical excision is suggested for mild-to-moderate HS, with wide excision for more extensive disease. Despite a paucity of good-quality data on management decisions in HS, this systematic review has enabled the development of robust and easily applicable clinical recommendations for international physicians based on graded evidence.
Effects of a cream containing 5% hyaluronic acid mixed with a bacterial-wall-derived glycoprotein, glycyrretinic acid, piroctone olamine and climbazole on signs, symptoms and skin bacterial microbiota in subjects with seborrheic dermatitis of the face. [2020]Objective: A new cream formulation containing hyaluronic acid 5%, complexed with a mix of a bacterial-wall-derived glycoprotein and peptide glycan complex (EDS), has been recently developed. We evaluated in a prospective, assessor-blinded, 6-week study the efficacy and tolerability of EDS in the treatment of facial seborrheic dermatitis (SD) and the effects on skin microbiota. Subjects and methods: Seventy-five subjects (mean age 46; 60 men) with moderate-severe SD of the face were enrolled. EDS cream was applied twice daily. The primary outcome was the evolution of the Investigator Global Assessment (IGA) score, evaluating erythema, scale/flaking, grade of seborrhea and itch. Superficial skin bacterial microbiome at baseline and after treatment was assessed, using the 16S rRNA gene methodology, in affected and non-affected face areas. Local tolerability was evaluated checking self-reported side effects at each visit. Results: Baseline IGA scores (mean±SD) was 10±3. The use of EDS reduced IGA score significantly by 70% at week 3 and by 88% at week 6. An increase in the abundance of Cutibacterium acnes genera associated with a significant drop of Staphylococcus genera presence was detected in affected areas. The ratio of relative abundance of genera Cutibacterium/Staphylococcus increased significantly after treatment in affected areas. The product was very well tolerated. Conclusion: Treatment with EDS applied twice daily for 6 consecutive weeks was associated with a reduction of the signs and symptoms of SD. Furthermore, after EDS cream treatment, a reequilibrating effect on facial skin microbiota was observed. The product was very well tolerated.
Injection Site Reactions in the Federal Adverse Event Reporting System (FAERS) Post-Marketing Database Vary Among Biologics Approved to Treat Moderate-To-Severe Psoriasis. [2021]Biologics used to treat moderate-to-severe plaque psoriasis may cause injection site reactions (ISRs) characterized by erythema, edema, itch, and sometimes pain. The Federal Adverse Event Reporting System (FAERS) is a repository of spontaneous post-marketing reports of adverse events (AEs) that are reported to the US Food and Drug Administration (FDA). Our objective was to perform a pharmacovigilance analysis of FAERS reports of ISRs associated with the use of subcutaneously administered biologic products approved to treat moderate-to-severe plaque psoriasis.
Mometasone furoate-loaded aspasomal gel for topical treatment of psoriasis: formulation, optimization, in vitro and in vivo performance. [2022]Present investigation was aimed to develop aspasomal gel of Mometasone Furoate for the treatment of Psoriasis that are biologically active and deliver drug at controlled rate and decrease dosing frequency.
Treatment Outcomes of IL-17 Inhibitors in Hidradenitis Suppurativa: A Systematic Review. [2022]The IL-17 pathway is a potential therapeutic target shown to be implicated in hidradenitis suppurativa (HS), however, it remains unclear whether evidence from mechanistic studies may translate into clinical practice. This systematic review summarizes available treatment outcomes of IL-17 inhibitors in patients with HS. Embase, MEDLINE, PubMed, and clinicaltrials.gov were comprehensively searched on February 26, 2021 to include 16 original studies representing 128 patients with HS (mean age: 36.5 years; age range: 21-47 years; male: 50.0%). Treatment outcomes were reported for the following biologics: secukinumab (n = 105), brodalumab (n = 22), and ixekizumab (n = 1). Patients were classified as responders or non-responders according to achievement of a positive response/improvement based on criteria established for each included study. For secukinumab 57.1% (n = 60/105) of patients were responders in a mean response period of 16.2 weeks and 42.9% (n = 45/105) were non-responders; for brodalumab, 100.0% (n = 22/22) of patients were responders within 4.4 weeks; and the one patient treated with ixekizumab was a responder within 10 weeks. In conclusion, IL-17 inhibitors may serve as an effective therapeutic target in approximately two-thirds of patients with HS and can be considered in those who are refractory to other treatment modalities. We also stress the importance of consistent outcome measures to enhance evidence synthesis, decrease reporting bias, provide potential for future meta-analysis, and ultimately improve clinical outcomes for patients with HS.
COSMOS next generation - A public knowledge base leveraging chemical and biological data to support the regulatory assessment of chemicals. [2023]The COSMOS Database (DB) was originally established to provide reliable data for cosmetics-related chemicals within the COSMOS Project funded as part of the SEURAT-1 Research Initiative. The database has subsequently been maintained and developed further into COSMOS Next Generation (NG), a combination of database and in silico tools, essential components of a knowledge base. COSMOS DB provided a cosmetics inventory as well as other regulatory inventories, accompanied by assessment results and in vitro and in vivo toxicity data. In addition to data content curation, much effort was dedicated to data governance - data authorisation, characterisation of quality, documentation of meta information, and control of data use. Through this effort, COSMOS DB was able to merge and fuse data of various types from different sources. Building on the previous effort, the COSMOS Minimum Inclusion (MINIS) criteria for a toxicity database were further expanded to quantify the reliability of studies. COSMOS NG features multiple fingerprints for analysing structure similarity, and new tools to calculate molecular properties and screen chemicals with endpoint-related public profilers, such as DNA and protein binders, liver alerts and genotoxic alerts. The publicly available COSMOS NG enables users to compile information and execute analyses such as category formation and read-across. This paper provides a step-by-step guided workflow for a simple read-across case, starting from a target structure and culminating in an estimation of a NOAEL confidence interval. Given its strong technical foundation, inclusion of quality-reviewed data, and provision of tools designed to facilitate communication between users, COSMOS NG is a first step towards building a toxicological knowledge hub leveraging many public data systems for chemical safety evaluation. We continue to monitor the feedback from the user community at support@mn-am.com.